MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE 5 DEGREES LEFT MEDIAL/RIGHT LATERAL; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: switzerland.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 00590102000 headless trocar drill pin 3.2 mm dia75 mm length, lot# unk, mdr: 0001822565-2022-02846.
Event or Problem Description
The warehouse received a cutting block with a pin stuck in a hole.The pin is broken.Items were in a loaner set.No additional information.
Additional Manufacturer Narrative
(b)(4). this follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10   visual examination of the returned product identified the guide showed signs of repeated use.A trocar pin has been seized into one of the guide's holes.The tip of the trocar pin has been fractured off and was not returned.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIAL CUT GUIDE 5 DEGREES LEFT MEDIAL/RIGHT LATERAL
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15511987
• Report Number: 0001822565-2022-02845
• Device Sequence Number: 14932650
• Product Code: HSX
• UDI-Device Identifier: 00889024582842
• UDI-Public: (01)00889024582842(10)64803698
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42539905195
• Device Lot Number: 64803698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown